cagrilintide/semaglutide (CagriSema) / Novo Nordisk - LARVOL DELTA

REIMAGINE 5: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both (clinicaltrials.gov) - P3 | N=1023 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Symposium - Efficacy and Safety of CagriSema 2.4mg/2.4mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 Clinical Trials (ADA 2025) - No abstract available

Clinical • Metabolic Disorders • Obesity

Cagrisema-Induced Weight Loss in Diet-Induced Obese Rats Relies on Preserved Mitochondrial Leak Respiration in Skeletal Muscle (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Preclinical • Metabolic Disorders • Obesity

A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo (clinicaltrials.gov) - P2 | N=618 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Diabetes • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus • CST3

Next-gen weight-loss drugs will be here within 12 months (New Atlas) - "...the Danish pharmaceutical company has announced it will seek regulatory approval in the first quarter of 2026 for CagriSema."

Approval • Obesity

Incretin-based therapies for the treatment of obesity-related diseases (ATTD 2025) - "Liraglutide, semaglutide and tirzepatide are incretin-based therapies currently approved by FDA for the management of obesity, while triple GIPR/GCGR/GLP-1R agonist retatrutide (LY3437943), the cagrilintide/semaglutide (CagriSema) 2.4 mg combination, high-dose oral semaglutide, and oral orforglipron are in advanced stages of development...Liraglutide, semaglutide and tirzepatide are incretin-based therapies currently approved by FDA for the management of obesity, while triple GIPR/GCGR/GLP-1R agonist retatrutide (LY3437943), the cagrilintide/semaglutide (CagriSema) 2.4 mg combination, high-dose oral semaglutide, and oral orforglipron are in advanced stages of development...Moreover, incretin-based therapies have also been proven beneficial on obesity-related comorbidities, such as knee osteoarthritis (KOA), obstructive sleep apnea (OSA) syndrome, and MASLD. Further research is needed to improve our understanding of their effects on obesity-related comorbidities and the..."

Cardiovascular • Congestive Heart Failure • Diabetes • Genetic Disorders • Heart Failure • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Obstructive Sleep Apnea • Osteoarthritis • Pain • Respiratory Diseases • Rheumatology • Sleep Disorder • Type 2 Diabetes Mellitus

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities. (PubMed, Peptides) - "Recent studies with peptide-based incretin herapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP)...New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The..."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Obstructive Sleep Apnea • Orthopedics • Renal Disease • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

REDEFINE 2: A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (clinicaltrials.gov) - P3 | N=1200 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight (clinicaltrials.gov) - P3 | N=331 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk A/S: CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial (GlobeNewswire) - P3 | N=1,200 | REDEFINE 2 (NCT05394519) | Sponsor: Novo Nordisk A/S | "Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight of 102 kg. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo....The detailed results from REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025."

P3 data • Obesity • Type 2 Diabetes Mellitus

REDEFINE 6: A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight (clinicaltrials.gov) - P3 | N=300 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity • Type 2 Diabetes Mellitus

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=134 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

Emerging pharmacotherapies for obesity: A systematic review. (PubMed, Pharmacol Rev) - "Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, and TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide and survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate...This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives."

Journal • Review • Genetic Disorders • Obesity

A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=134 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P2 trial • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

Novo charts course ahead for CagriSema after lacklustre data (pharmaphorum) - "The key to unlocking the drug's potential will be a new trial due to start in the first half of this year that will include a new personalised approach to dosing with CagriSema and a longer period of follow-up, according to Martin Holst Lange, Novo Nordisk's head of development...Meanwhile, rather than just reducing dose, the plan in the new trial is to allow for CagriSema to be increased again if side effects resolve, which Novo Nordisk believes could 'potentially enhance efficacy of CagriSema while maintaining a favourable safety profile.'....The new trial will be called REDEFINE 11 and is due to start in the first half of this year. In the meantime, attention is on the results of the REDEFINE 2 trial before the end of the first quarter – as Novo Nordisk prepares for a possible CagriSema filing in early 2026..."

Filing • New trial • P3 data • Obesity • Type 2 Diabetes Mellitus

CagriSema: “CagriSema demonstrated 22.7% weight loss in REDEFINE 1”; Obesity (Novo Nordisk) - Q4 & FY2024 Results

P3 data • Obesity

A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P3 trial • Genetic Disorders • Obesity

A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Novo Nordisk A/S | Trial primary completion date: May 2024 ➔ Oct 2024

Trial primary completion date • Genetic Disorders • Obesity

A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed | N=180 ➔ 55 | Trial primary completion date: Nov 2024 ➔ May 2024

Enrollment change • Trial completion • Trial primary completion date • Genetic Disorders • Obesity

A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

REIMAGINE 1: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels (clinicaltrials.gov) - P3 | N=7000 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular